80 FR 66906 - Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 210 (October 30, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.'' This revised draft guidance document replaces the draft of the same name that published on August 21, 2002. This revised draft guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) reviewed by the Center for Drug Evaluation and Research (CDER).

[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Notices]
[Pages 66906-66907]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27744]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2002-D-0093 (Formerly Docket ID 2002D-0337)]


Liposome Drug Products: Chemistry, Manufacturing, and Controls; 
Human Pharmacokinetics and Bioavailability; and Labeling Documentation; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised draft guidance for industry entitled 
``Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human 
Pharmacokinetics and Bioavailability; and Labeling Documentation.'' 
This revised draft guidance document replaces the draft of the same 
name that published on August 21, 2002. This revised draft guidance 
provides recommendations to applicants on the chemistry, manufacturing, 
and controls (CMC); pharmacokinetics and bioavailability; and labeling 
documentation for liposome drug products submitted in new drug 
applications (NDAs), abbreviated new drug applications (ANDAs), and 
biologics license applications (BLAs) reviewed by the Center for Drug 
Evaluation and Research (CDER).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 29, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2002-D-0093 (formerly docket ID 2002D-0337) for ``Liposome Drug 
Products: Chemistry, Manufacturing, and Controls; Human 
Pharmacokinetics and Bioavailability; and Labeling Documentation.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive

[[Page 66907]]

label to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Richard T. Lostritto, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4148, Silver Spring, MD 20993-0002, 301-
796-1697.

SUPPLEMENTARY INFORMATION: 

I. Background

    The FDA is announcing the availability of a revised draft guidance 
for industry entitled ``Liposome Drug Products: Chemistry, 
Manufacturing, and Controls; Human Pharmacokinetics and 
Bioavailability; and Labeling Documentation.'' This revised draft 
guidance provides recommendations to applicants on the CMC, human 
pharmacokinetics and bioavailability, and labeling documentation for 
liposome drug products submitted in NDAs, ANDAs, and BLAs reviewed by 
CDER. This revision adds BLAs and ANDAs. It also updates the 
discussions on liposome technology.
    In the Federal Register of August 21, 2002 (67 FR 54220), FDA 
announced the availability of a draft version of this guidance. FDA 
received comments in response to the draft guidance, and this revised 
guidance reflects FDA's careful consideration of these comments. Most 
of the changes to the revised draft guidance were made to clarify 
statements in the 2002 draft guidance. In addition, FDA decided to 
publish a revised draft guidance because of changes in technology since 
the draft was first published in 2002, the addition of BLAs reviewed by 
CDER as a result of a CDER and Center for Biologics Evaluation and 
Research reorganization in 2003, and the addition of ANDAs.
    The revised draft guidance does not provide recommendations on 
clinical efficacy and safety studies, nonclinical pharmacology and/or 
toxicology studies, liposome formulations of vaccine adjuvants or 
biologics, or drug-lipid complexes.
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). This revised draft 
guidance, when finalized, will represent the Agency's current thinking 
on liposome drug products. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This revised draft guidance refers to previously approved 
collections of information that are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part 
314 have been approved under OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the Internet may obtain the revised draft 
guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27744 Filed 10-29-15; 8:45 am]
BILLING CODE 4164-01-P